Pfizer has obtained FDA approval for the expanded use of Prevnar 13, pneumococcal conjugate vaccine, in children and adults between six to 17 years of age who are new to the vaccine. The single dose Pneumococcal 13-valent conjugate ...
Tags: FDA, vaccine, conjugate vaccine
The US Food and Drug Administration (FDA) has approved L300 neurostimulation system, designed for treating children suffering from foot drop. The neuromuscular stimulation device, which also helps in treating children suffering from ...
Tags: FDA, L300 neurostimulation system, children, foot drop
The USFDA has approved Allergan's Botox (onabotulinumtoxinA) as overactive bladder (OAB) therapy for adults who do not respond to or who cannot tolerate an anticholinergic medication. The approval was based on safety and efficacy data ...
Tags: FDA, Allergan overactive bladder, anticholinergic treatments
Sanovas has filed Vas Zeppelin Smart Catheter's application with the US Food and Drug Administration (FDA) for approval. The miniaturized interventional catheter, which the company claims is the smallest interventional catheters ...
Tags: Sanovas, Vas Zeppelin Smart Catheter, FDA
NanoSmart Pharmaceuticals and University of California Los Angeles (UCLA) have signed a research alliance to advance the development of the drug delivery platform that uses human autoimmune antibodies targeting several tumor types. ...
Santarus has obtained FDA approval for ulcerative colitis therapy, Uceris (budesonide) extended release tablets. A 9mg dose tablet is approved for administration once a day in adult patients with ulcerative colitis for up to eight weeks. ...
The US Food and Drug Administration (FDA) has cleared the use of Hologic's amplified nucleic acid assay on the company's fully-automated Panther system. Using endocervical or vaginal swabs and specimens, collected in Hologic's ThinPrep ...
Tags: FDA, Hologic, Panther system, Trichomonas vaginalis assay
Brainsway has gained US marketing rights for its Deep transcranial magnetic stimulation (TMS) device, designed for use in patients with depression, who have failed to respond to antidepressant medications, following the US Food and Drug ...
BioPhotas has gained the US marketing rights for its light therapy device,designed to treat acne,muscle and joint pain,muscle and joint stiffness,muscle spasm,arthritis and compromised local blood circulation,following the US Food and Drug ...
Famy Care has won final FDA approval for abbreviated new drug application (ANDA) of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15mg/0.03mg, generic equivalent to Teva Branded Pharmaceutical Products' Nordette 28 tablets. Mylan ...
Tags: Medicine
EMD Serono, a subsidiary of Merck, and Pfizer have announced the FDA approval of Rebif Rebidose (interferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (MS). Rebif Rebidose was designed as single-use auto-injector ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to Alphatec Holdings' new products, Pegasus and ILLICO FS Facet Fixation systems. Pegasus, an anchored anterior cervical interbody device, offers single-step deployment ...
Tags: MIS Systems, Alphatec, FDA Approval, New Anterior Cervical Interbody
Dune Medical Devices' MarginProbe system, designed for the detection of breast cancer, has obtained premarket approval (PMA) from the US Food and Drug Administration (FDA). The system is an intra-operative tissue assessment tool which ...
Tags: Dune Medical, FDA Approval, Breast Cancer Detection Device, Medicine
Janssen Therapeutics has obtained accelerated approval from FDA for Sirturo (bedaquiline) tablets as part of combination therapy to treat adult patients with pulmonary multi-drug resistant tuberculosis (MDR-TB). The surrogate endpoint of ...
Tags: Janssen Therapeutics, accelerated approval, FDA, Sirturo tablets
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Medical Modeling's Virtual Surgical Planning (VSP) system product line. The products, which utilize the company's VSP system technology, include VSP Orthognathics ...
Tags: FDA, VSP system product line, US, approval